1°CSeptember 05, 2018
Tag: FDA , Drugs Approval , in 2018
FDA’s Review Progress of Noteworthy Pharmaceutical Products in the Second Half of the Year
II. Drugs that have been completed marketing application but whose PDUFA dates are not determined
According to the disclosed information, besides the drugs mentioned above that are under review, the marketing applications of 4 drugs have been completed, but their PDUFA dates have not been determined, including 1 long-acting factor VIII NN7088, AbbVie’s anti-IL-23A monoclonal antibody risankizumab, and Amgen’s romosozumab that was resubmitted the marketing application.
Drug |
Indication |
Mechanism of action |
PDUFA |
Company |
Application type |
Remarks |
NN7088 |
Hemophilia A |
factor VIII |
Unknown at the moment |
Novo Nordisk |
BLA |
None |
risankizumab |
Moderate-to-severe plaque psoriasis |
Anti-IL-23A monoclonal antibody |
Unknown at the moment |
AbbVie |
BLA |
Completed application on April 25, 2018 |
tagraxofusp |
Blastic plasmacytoid dendritic cell neoplasm |
IL-3Rα |
Unknown at the moment |
Stemline Therapeutics |
BLA |
Completed rolling submission on June 25, 2018 |
romosozumab |
Osteoporosis |
Anti-SOST monoclonal antibody |
2019 |
Amgen/UCB |
BLA |
Resubmitted application on July 12, 2018 |
III. The indication extension applications of concern
Besides the NDAs/BLAs mentioned above, the indication extension applications of several blockbuster drugs are also listed here, such as the sBLA for Roche’s Tecentriq as first-line therapy for non-squamous NSCLC, and the sBLA for MSD’s Keytruda against squamous NSCLC, which will not be detailed here.
Drug |
Indication |
Mechanism of action |
PDUFA |
Company |
Application type |
Tecentriq |
First-line therapy for non-squamous NSCLC |
Anti-PD-L1 monoclonal antibody |
September 5, 2018 |
Roche |
sBLA |
Hemlibra |
Patients with hemophilia A without factor VIII inhibitors |
F IXa/F X bispecific antibody |
October 14, 2018 |
Roche |
sBLA |
Hemlibra |
New dosing regimens |
F IXa/F X bispecific antibody |
October 14, 2018 |
Roche |
sBLA |
keytruda |
Squamous NSCLC |
Anti-PD-1 monoclonal antibody |
October 30, 2018 |
MSD |
sBLA |
Keytruda |
Anti-PD-1 monoclonal antibody |
Advanced hepatocellular carcinoma |
November 9, 2018 |
MSD |
sBLA |
eltrombopag |
First-line therapy for aplastic anemia |
TPO receptor agonist |
Second half of 2018 |
Novartis |
sNDA |
2018 will be another big year of FDA review, with the marketing of many blockbuster drugs highly anticipated. The marketing progress of global blockbuster innovative drugs will be further accelerated and the global drug review and approval dynamics are worthier of attention, as the drug review and approval reform of the State Drug Administration of China further advances, especially after the release of the Notice on Soliciting Opinions on the List of Clinically Imperative New Drugs that are Marketed Overseas and the full implementation of acceptance of overseas clinical data in China.
Read more: Drugs Approved by FDA Expected to Exceed 50 in 2018
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